FDA Approves Yutiq (fluocinolone acetonide intravitreal implant) for Chronic Non-Infectious Posterior Segment Uveitis
WATERTOWN, Mass., Oct. 15, 2018 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, announced today that the U. S. Food... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 15, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xarelto to Reduce the Risk of Major Cardiovascular Events in Patients with Chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD)
TITUSVILLE, NJ, October 11, 2018 – The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Xarelto (rivaroxaban) to reduce the risk of major cardiovascular (CV)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 11, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Accelerated 7-Day Vaccine Dosing Schedule for Ixiaro
GAITHERSBURG, Md.--(BUSINESS WIRE) October 05, 2018 --Valneva USA, the U.S. subsidiary of global vaccine biotech company Valneva SE, today announced U.S. Food and Drug Administration (FDA) approval of an accelerated dosing regimen for Ixiaro... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 5, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tegsedi (inotersen) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis
BOSTON and CARLSBAD, Calif., Oct. 05, 2018 (GLOBE NEWSWIRE) -- Akcea Therapeutics, Inc. (NASDAQ: AKCA), an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), announced today that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 5, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Revcovi (elapegademase-lvlr) for Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID)
GAITHERSBURG, Md.--(BUSINESS WIRE) October 05, 2018 --Leadiant Biosciences, Inc. today announced that the Food and Drug Administration (FDA) has granted approval to Revcovi ™ (elapegademase-lvlr) injection in the U.S. Revcovi is a new enzyme... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 5, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Expanded Use of Gardasil 9 to Include Individuals 27 Through 45 Years Old
October 5, 2018 -- The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 5, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech ’s Hemlibra (emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors
South San Francisco, CA -- October 4, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Hemlibra ® (emicizumab-kxwh) for routine prophylaxis to... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 4, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Nuzyra (omadacycline) for Community-Acquired Bacterial Pneumonia and Acute Skin and Skin Structure Infections
BOSTON, Oct. 02, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) today announced that the U.S. Food and Drug Administration (FDA) has approved Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 2, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Seysara (sarecycline) for the Treatment of Moderate to Severe Acne
Barcelona - 2nd October 2018 -- Almirall, S.A. announced today that the Food and Drug Administration (FDA) has approved Seysara (sarecycline), a new, innovative first in class tetracycline-derived oral antibiotic for the treatment of inflammatory... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 2, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xyosted (testosterone enanthate) Injection for Testosterone Replacement Therapy in Adult Males
EWING, N.J., Oct. 01, 2018 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) today announced the approval of Xyosted (testosterone enanthate) injection by the U.S. Food and Drug Administration (FDA). Xyosted is the first FDA approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 1, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Kyprolis (carfilzomib) Once-Weekly Kd70 Regimen for Relapsed or Refractory Multiple Myeloma
THOUSAND OAKS, Calif., Oct. 1, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for Kyprolis... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 1, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Arikayce (amikacin liposome inhalation suspension) to treat Mycobacterium Avium Complex (MAC) Lung Disease
September 28, 2018 -- The U.S. Food and Drug Administration today approved a new drug, Arikayce (amikacin liposome inhalation suspension), for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex (MAC) in a... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Libtayo (cemiplimab-rwlc) for Advanced Cutaneous Squamous Cell Carcinoma
September 28, 2018 -- The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech's Xolair (omalizumab) Prefilled Syringe Formulation
South San Francisco, CA -- September 28, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Fycompa for the Treatment of Partial-Onset Seizures in Pediatric Patients as Young as 4 Years Old
WOODCLIFF LAKE, N.J., Sept. 28, 2018 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) expanded the indication of its antiepileptic drug Fycompa (perampanel) CIII for monotherapy and adjunctive use in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2018 Category: Drugs & Pharmacology Source Type: news

Eisai Announces FDA Approval of Fycompa in Pediatric Patients as Young as 4 Years Old for the Treatment of Partial-Onset Seizures
WOODCLIFF LAKE, N.J., Sept. 28, 2018 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) expanded the indication of its antiepileptic drug Fycompa (perampanel) CIII for monotherapy and adjunctive use in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Vizimpro (dacomitinib) for the First-Line Treatment of Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer
September 27, 2018 - Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Vizimpro [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 27, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Emgality (galcanezumab-gnlm) for the Preventive Treatment of Migraine in Adults
INDIANAPOLIS, Sept. 27, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Emgality (galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 27, 2018 Category: Drugs & Pharmacology Source Type: news

Adamis Pharmaceuticals Receives FDA Approval for Its Lower Dose Symjepi Product
SAN DIEGO, Sept. 27, 2018 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) ( “Adamis”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved Adamis’ lower dose version (0.15mg) of Symjepi for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 27, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Copiktra (duvelisib) Capsules for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma
BOSTON--(BUSINESS WIRE)--Sep. 24, 2018-- Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced that the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 24, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ajovy (fremanezumab-vfrm) for Preventive Treatment of Migraine
September 14, 2018 -- Today, the US Food and Drug Administration (FDA) approved Ajovy (fremanezumab-vfrm) for the preventive treatment of migraine in adults. Ajovy is the second FDA-approved preventive migraine treatment in a new class of drugs that... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 14, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xelpros (latanoprost ophthalmic emulsion) to Treat Open-angle Glaucoma or Ocular Hypertension
MUMBAI, India& PRINCETON, N.J.--(BUSINESS WIRE) September 14, 2018 --Sun Pharmaceutical Industries Ltd. and Sun Pharma Advanced Research Company Ltd. (SPARC) today announced U.S. Food and Drug Administration (USFDA) approval for the New Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 14, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA)
South San Francisco, CA -- September 13, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 13, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lumoxiti (moxetumomab pasudotox-tdfk) for Hairy Cell Leukemia
September 13, 2018 -- The U.S. Food and Drug Administration today approved Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 13, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Cassipa (buprenorphine and naloxone) Sublingual Film as Maintenance Treatment for Opioid Dependence
September 7, 2018 -- The U.S. Food and Drug Administration today approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence. This action provides a new dosage strength... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 7, 2018 Category: Drugs & Pharmacology Source Type: news

ITF Pharma Announces FDA Approval of Tiglutik (riluzole) Oral Suspension for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
BERWYN, Pa., Sept. 6, 2018 /PRNewswire/ -- ITF Pharma, a U.S.-based specialty pharmaceutical company and a subsidiary of Italfarmaco, a privately-held European specialty pharmaceutical company, committed to investing in and commercializing impactful... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 6, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Merck ’s Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) for the Treatment of HIV-1 in Appropriate Patients
KENILWORTH, N.J.--(BUSINESS WIRE) August 30, 2018 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Delstrigo, a once-daily fixed-dose combination... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 30, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Merck ’s Pifeltro (doravirine) for the Treatment of HIV-1 in Appropriate Patients
KENILWORTH, N.J.--(BUSINESS WIRE) August 30, 2018 --Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Pifeltro (doravirine, 100 mg), a new... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 30, 2018 Category: Drugs & Pharmacology Source Type: news

Bayer Receives FDA Approval for Jivi (antihemophilic factor (recombinant), PEGylated-aucl) for Prophylactic Treatment of Hemophilia A
WHIPPANY, N.J., Aug. 30, 2018 /PRNewswire/ -- Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Jivi ® (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 30, 2018 Category: Drugs & Pharmacology Source Type: news

Tetraphase Pharmaceuticals Announces FDA Approval of Xerava (eravacycline) for Complicated Intra-Abdominal Infections (cIAI)
WATERTOWN, Mass., Aug. 27, 2018 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 27, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Imbruvica (ibrutinib) Plus Rituximab for Patients with Waldenstr öm’s Macroglobulinemia
HORSHAM, Pa., August 27, 2018 – The Janssen Pharmaceutical Companies of Johnson& Johnson today announced the U.S. Food and Drug Administration (FDA) approval of Imbruvica (ibrutinib) in combination with rituximab for the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 27, 2018 Category: Drugs & Pharmacology Source Type: news

Ortho Dermatologics Receives FDA Approval for Altreno (tretinoin 0.05%) Lotion For Acne
LAVAL, Quebec, Aug. 24, 2018 /PRNewswire/ -- Ortho Dermatologics, one of the largest prescription dermatology health care businesses in the world and a division of Bausch Health Companies Inc. (NYSE/TSX: BHC), today announced that the U.S. Food and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 24, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Takhzyro (lanadelumab-flyo) for Hereditary Angioedema
August 23, 2018 -- The U.S. Food and Drug Administration today approved Takhzyro (lanadelumab), the first monoclonal antibody approved in the U.S. to treat patients 12 years and older with types I and II hereditary angioedema (HAE). HAE is a rare... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 23, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Inveltys (loteprednol etabonate) for Post-Operative Inflammation and Pain Following Ocular Surgery
WALTHAM, Mass.--(BUSINESS WIRE)--Aug. 23, 2018-- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary mucus-penetrating particle (MPP)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 23, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Oxervate (cenegermin) for Neurotrophic Keratitis
August 22, 2018 -- The U.S. Food and Drug Administration today approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 22, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Diacomit (stiripentol) for Seizures Associated with Dravet Syndrome
On August 20, 2018, the U.S. Food and Drug Administration (FDA) approved Diacomit (stiripentol) for seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam. Dravet syndrome is a rare genetic condition that... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Expanded Label for Merck ’s Keytruda (pembrolizumab) in Patients with Metastatic Nonsquamous NSCLC with No EGFR or ALK Genomic Tumor Aberrations
KENILWORTH, N.J.--(BUSINESS WIRE) August 20, 2018 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for Keytruda, Merck ’s... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves New Eylea (aflibercept) Injection Dosing Schedule in Wet Age-Related Macular Degeneration
TARRYTOWN, N.Y., Aug. 17, 2018 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ : REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Eylea (aflibercept)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 17, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Opdivo (nivolumab) for Certain Patients with Previously Treated Small Cell Lung Cancer
PRINCETON, N.J.--(BUSINESS WIRE)--August 17, 2018 -- Bristol-Myers Squibb Company (NYSE:BMY) today announced that Opdivo (nivolumab) received approval from the U.S. Food and Drug Administration (FDA) as the first and only Immuno-Oncology treatment... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 17, 2018 Category: Drugs & Pharmacology Source Type: news

Sun Pharma Announces FDA Approval of Cequa (cyclosporine) Ophthalmic Solution to Treat Dry Eye Disease
MUMBAI, India& PRINCETON, N.J.--(BUSINESS WIRE)-- August 16, 2018 -- Sun Pharmaceutical Industries Ltd. (Reuters:SUN.BO, Bloomberg:SUNP IN, NSE:SUNPHARMA, BSE:524715, “Sun Pharma” and includes its subsidiaries and/or associate companies)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lenvima (lenvatinib) for First-line Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Woodcliff Lake, NJ and Kenilworth, NJ, Aug. 16, 2018 – Eisai Inc. and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor Lenvima... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 12 to & lt;24 Months with Certain Mutations in the CFTR Gene
BOSTON--(BUSINESS WIRE)--Aug. 15, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved Kalydeco (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 15, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Galafold (migalastat) for the Treatment of Fabry Disease
August 10, 2018 -- The U.S. Food and Drug Administration today approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease. The drug is indicated for adults with Fabry disease who have a genetic mutation... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 11, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Annovera (segesterone acetate and ethinyl estradiol) Vaginal Contraceptive System
NEW YORK, Aug. 10, 2018 /PRNewswire/ -- The Population Council, a global nonprofit research organization, announced it has received U.S. Food and Drug Administration (FDA) approval for Annovera ™ (segesterone acetate and ethinyl estradiol vaginal... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 10, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Onpattro (patisiran) Targeted RNA-based Therapy for Polyneuropathy Caused by hATTR
August 10, 2018 -- The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 10, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Jornay PM (methylphenidate) Extended-Release Capsules for Attention Deficit Hyperactivity Disorder (ADHD)
GEORGE TOWN, Cayman Islands--(BUSINESS WIRE)August 09, 2018 --Ironshore Pharmaceuticals& Development, Inc. ( “Ironshore”) a wholly owned subsidiary of Highland Therapeutics Inc. (“Highland”) announced today that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 9, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Arakoda (tafenoquine) for the Prevention of Malaria
WASHINGTON, Aug. 9, 2018 /PRNewswire/ -- 60 Degrees Pharmaceuticals (60P) announced today the U.S. Food and Drug Administration (FDA) approval of Arakoda (tafenoquine) tablets for the prevention of malaria in patients aged 18 years and older. For... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 9, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Poteligeo (mogamulizumab-kpkc) for Mycosis Fungoides and S ézary Syndrome
August 8, 2018 -- The U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or S ézary syndrome (SS) after... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 8, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Expanded Indication for Orkambi (lumacaftor/ivacaftor) in Children Ages 2-5 Years
BOSTON--(BUSINESS WIRE)--Aug. 7, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved Orkambi (lumacaftor/ivacaftor) to include use in children ages 2 through 5 years with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 7, 2018 Category: Drugs & Pharmacology Source Type: news

Teva Announces Updated Indication and Vial Presentation for Granix (tbo-filgrastim) Injection in United States
JERUSALEM--(BUSINESS WIRE)--Aug. 6, 2018-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved Granix (tbo-filgrastim) Injection for a new vial presentation and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 6, 2018 Category: Drugs & Pharmacology Source Type: news